During this pilot study, we intend to investigate the feasibility of a home-based patient-tailored telemedicine self-management intervention for patients with COPD and chronic heart failure over a 4-month period.
ID
Source
Brief title
Condition
- Heart failures
- Bronchial disorders (excl neoplasms)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main study endpoints are the satisfaction of patients with and adherence to
(the different components of) the telemedicine self-management interventions.
Also, motivation of patients and health care providers to use the
self-management platform is one of the main study endpoints. Semi-structured
interviews with patients and case managers will be performed for a qualitative
evaluation of these endpoints. Other assessments of satisfaction will be the
Client Satisfaction Questionnaire and the rating of satisfaction by using a
four-point scale. Adherence to the different components of the telemedicine
self-management intervention will be assessed by the frequency and time that
patients use the different modules of the platform, the number of diary
completion and the frequency of acting according to action plans.
Secondary outcome
Secondary endpoints are: 1) the added value of the laboratory test NTproBNP to
differentiate between dyspnoea caused by exacerbations of COPD or of heart
failure during this self-management intervention (frequency of measuring
NTproBNP and frequency of treatment change according the NTproBNP, 2) inhaler
technique and patients* adherence to inhalation medication by using sensorised
inhalers and 3) improvement of inhaler technique and adherence after feedback
(by measuring and comparing these variables at the first, sixth and last week
of the study). We will assess the effects of the intervention on quality of
life by using questionnaires.
Background summary
COPD is a very common progressive lung disease with distressing COPD
exacerbations that accelerate the rate of lung function decline and thereby
cause a decrease in health status, activity and quality of life. COPD
self-management interventions are shown to have beneficial effects on
health-related quality of life, reduction of respiratory-related
hospitalisations and improvement of dyspnoea. Action plans for the
self-treatment of COPD exacerbations are an intrinsic component of
self-management programs. In the COPE-III study, a multi-centre randomized
controlled trial, patient tailored action plans for the early self-treatment of
deteriorating symptoms of COPD and comorbidities were developed. Positive
effects on COPD exacerbation duration and respiratory-related hospitalisation
rate were seen. Incorporating this self-management intervention in a home-based
digital platform with an avatar for personalized feedback may improve the
applicability of self-management interventions and could make it more
patient-tailored. It may lead to earlier recognition of worsening of symptoms
and quicker initiation of treatment because real time monitoring and prompt
feedback is possible. Because of these factors, the use of telemedicine may
improve the effectiveness of self-management interventions on health outcomes.
Study objective
During this pilot study, we intend to investigate the feasibility of a
home-based patient-tailored telemedicine self-management intervention for
patients with COPD and chronic heart failure over a 4-month period.
Study design
During this study, we will extend an existing COPD self-management telemedicine
platform that will include an automated decision support system of action plans
for exacerbations of COPD, heart failure and other comorbidities (ischemic
heart disease, anxiety, depression, diabetes). These action plans were proven
effective in the COPE-III study.
Intervention
First, patients will participate in three self-management courses. During the
use of the telemedicine self-management intervention (follow-up), patients will
complete their symptom diary every day. In case of symptom deterioration, the
telemedicine platform will automatically launch the action plan that indicates
what action should be taken (e.g., take prednisolone/antibiotics/furosemide).
Furthermore, NTproBNP will be tested in case of doubts whether increased
dyspnoea is caused by COPD or heart failure. Sensorised inhalers will be used
to monitor patients* inhaler technique and adherence. An avatar will give
personal feedback and reminders on patients* diary completion, action plan use
and use/technique of inhalers and will motivate patients to use the different
modules of the telemedicine platform.
Study burden and risks
The risk for adverse events due to participation in this study is negligible.
Patients will receive their usual care (e.g., by visits to their pulmonologist
and/or cardiologists) during the study. There is a chance that the patients who
self-treat their symptoms will use more medication then necessary, however, in
other studies on self-treatment of COPD patients (e.g COPE-III study), this was
not an issue. The telemedicine self-management intervention will be used by
health care providers with knowledge about and experience with COPD, heart
failure, self-management and inhalers.
Koningsplein 1
Enschede 7512 KZ
NL
Koningsplein 1
Enschede 7512 KZ
NL
Listed location countries
Age
Inclusion criteria
- A clinical diagnosis of COPD according to the GOLD 2017 criteria (Forced Expiratory Volume in one second (FEV1) < 80% of the predicted value and FEV1/Vital Capacity (FVC) < 0.70
- Chronic Heart Failure (CHF) defined according to the current (2016) ESC guidelines
- * 2 COPD and/or CHF exacerbations* and/or *1 hospitalisation for COPD and/or CHF in the two years preceding study entry
- * 40 years of age
- At least 1 week after prednisolone/antibiotics/furosemide course. At least 1 week after hospitalisation. At least 4 weeks post-rehabilitation.
- Able to understand and read the Dutch language
- Able to use a tablet
- Written informed consent from the subject prior to participation.
Exclusion criteria
- Terminal cancer or the end stage of another serious disease;
- Other serious lung disease (e.g. 1-antitrypsin deficiency; interstitial lung diseases);
- Expected cardiovascular intervention within three months.
- Being currently enrolled in randomized controlled trials or trial with study medication
- Waiting for a heart or lung transplantation
- Receiving of renal dialysis
- Diabetes Mellitus type I
- HADS (Hospital Anxiety and Depression Scale)-score of * 11 for depression and/or anxiety
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL62299.044.17 |